Effects of High Flow Nasal Cannula on Sputum Clearance in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT04217746 | Terminated FDA Device

• 1 other identifier: IRB#13356
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Acute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. Often patients complain of sensation of sputum (phlegm) stuck in throat, which leads to worsening cough and respiratory distress. In an acute exacerbation setting high flow nasal cannula (HFNC), which is a modality that provides humidified and warm oxygenated air at flow of upto 60L/min, has shown to reduce blood carbon dioxide level and respiratory rate. However, studies investigating other effects of HFNC in this setting are lacking. To investigators' knowledge, this is the first study investigating effects of HFNC on sputum clearance in COPD patients. The purpose of the study is to determine the effects of HFNC on sputum clearance in acute exacerbation of COPD. Primary objective of the study is to determine whether HFNC improves clearability and wettability of sputum produced during acute exacerbation of COPD. Secondary objectives of the study include subjective assessment of cough severity as well as need for escalation of care after HFNC use versus conventional flow nasal oxygen (CFNO) use.

Conditions

Chronic Obstructive Pulmonary Disease; COPD Exacerbation; Airflow Obstruction

Keywords

high flow nasal cannula; sputum; clearability; wetability; chronic obstructive pulmonary disease; COPD exacerbation

Outcome Measures

Primary Outcomes (6)

• Clearability of sputum sample at baseline

  Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.

  Sputum sample will be collected at time = 0 hours (baseline)

• Clearability of sputum sample at 6 hours

  Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.

  Sputum sample will be collected at time = 6 +/- 2 hours

• Clearability of sputum sample at 24 hours

  Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.

  Sputum sample will be collected at time = 24 +/- 2 hours

• Wettability of sputum sample at baseline

  Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.

  Sputum sample will be collected at time = 0 hours (baseline)

• Wettability of sputum sample at 6 hours

  Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.

  Sputum sample will be collected at time = 6 +/-2 hours

• Wettability of sputum sample at 24 hours

  Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.

  Sputum sample will be collected at time = 24 +/-2 hours

Secondary Outcomes (3)

• Change in cough severity

  Visual analogue score regarding cough severity will be obtained at time = 0 hours (baseline), and time = 24 hours.

• Change in cough frequency and easiness

  Breathlessness, Cough and Sputum Scale (BCSS) regarding cough frequency and ease will be obtained at time = 0 hours (baseline), and time = 24 hours.

• Number of participants with need for escalation of care

  Need for escalation will be documented at any time throughout subject's participation which is upto 24 hours.

Study Arms (2)

High flow nasal cannula (HFNC) group

EXPERIMENTAL

The HFNC group will receive heated (approximately 37 ⁰C) and humidified (100% relative humidity) oxygenated gas delivered at high flow at 50L/min. Flow could be decreased to as low as 30L/min and temperature to 31 ⁰C as per patient's tolerance.

Device: High Flow Nasal Cannula

Conventional flow nasal oxygen (CFNO) group

NO INTERVENTION

The conventional flow nasal oxygen (CFNO) group is the control group which will receive ambient temperature and non-humidified oxygen delivered at flow rates of up to 8L/min (standard care).

Interventions

High Flow Nasal Cannula DEVICE

The HFNC group will receive heated and humidified oxygenated gas delivered at high flow.

Also known as: Fisher and Paykel AIRVO humidified high flow system

High flow nasal cannula (HFNC) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Known COPD or high probability of the disease according to treating physician based on clinical history, physical examination and chest imaging.
• Hospital admission for acute exacerbation of COPD defined by 2018 GOLD report as acute worsening of respiratory symptoms (more than baseline cough, sputum purulence or volume, dyspnea or wheeze) that result in additional therapy.
• Presence of one or more of following: increase in sputum production, change in sputum color or difficulty in expectorating sputum.

You may not qualify if:

• Inability to obtain informed consent from the patient or legally authorized representative.
• Inability of the subject to cooperate with protocol.
• Presence of idiopathic bronchiectasis or cystic fibrosis.
• Patients with poor short term prognosis not expected to survive the hospitalization.
• Massive hemoptysis.
• Patients presenting with coma (Glasgow coma scale \<10) or circulatory shock.
• Respiratory failure requiring non-invasive ventilation (NIV) or endotracheal intubation.
• Severely impaired cough, impaired swallowing or chronic aspiration due to neuromuscular disorder.
• Facial deformity or injury leading to difficulty in wearing high flow nasal cannula appropriately.
• Enrollment in other investigative protocols with apparent overlap.
• Prisoners

Sponsors & Collaborators

• Tufts Medical Center: lead
• Virginia Commonwealth University: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas Hill, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: January 3, 2020
• Study Start: February 1, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)